Sept. 11, 2001
     Non-Hodgkins Lymphoma

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FDA panel backs new drug for non-Hodgkin's Lymphoma

BETHESDA, Md. -- Sept. 11, 2001 (Cancer Digest)-- An advisory panel for the FDA today recommended approval of a new drug that delivers radiation to individual non-Hodgkin's Lymphoma cells in patients who have become resistant to another drug called Rituxan. The panel also recommended an accelerated approval process for using the drug in those patients who have not yet been treated with Rituxan.

The FDA usually follows the advice of its advisory panels. Members of the advisory panel were excited about the drug's effectiveness in shrinking tumors for many patients.

"We wanted the drug out there... that's why we voted for accelerated approval," said Dr. Stacy Nerenstone, who chaired the Oncologic Drugs Advisory Committee. "Our concerns are with the toxicity and that it not be used before Rituxan," she said.

Non-Hodgkin's lymphomas are a group of related cancers that originate in the lymphatic system and usually spread throughout the body. About 50,000 new cases of all types are diagnosed in the United States each year.

The new drug called Zevelin, made by IDEC Pharmaceuticals, uses an engineered antibody coupled to a radioactive isotope to deliver the radiation directly to cancerous lymph cells that display a particular protein on the cell surface. The technique is called radioimmunotherapy because it uses the immune system to deliver radiation to cancer cells.

The company also makes Rituxan, another engineered antibody, that uses a different mechanism to kill cells. It was the first engineered antibody to be FDA-approved for treatment of cancer.

In one trial, 51 percent of patients who had stopped responding to Rituxan benefited from a single dose of Zevalin. Side effects include a possible reduction of infection-fighting whiteblood cells.

The FDA's Center for Drug Evaluation and Research said the agency would now work out the details of the accelerated approval process with IDEC and expects to complete its review of Zevalin by Jan. 8.

In a related development, Corixa, Inc. and GlaxoSmithKline today filed a complaint in Delaware District Court for patent infringement against IDEC Pharmaceuticals Corporation.

The complaint alleges that IDEC's activities going forward since the Oncologic Drugs Advisory Committee's recommendation for approval of Zevalin(TM) infringe, and/or will infringe, patents held by Corixa.
The legal battle, however, is not expected to interfere in the FDA-approval process. Corixa states in a press release, "It is our desire to protect our intellectual property without limiting patients' access to radioimmunotherapy. Therefore, we are willing to work constructively with IDEC toward that goal and have extended an offer to discuss licensing of Corixa's patents."